alexa Validation of bioanalytical methods.
Pharmaceutical Sciences

Pharmaceutical Sciences

Pharmaceutica Analytica Acta

Author(s): Karnes HT, Shiu G, Shah VP

Abstract Share this page

Abstract Validation of bioanalytical methods used to generate data for pharmacokinetic and bioavailability studies is approached by a variety of techniques and is subject to many different methods of interpretation. This Review puts the various techniques into perspective and discusses pitfalls which may occur in interpretation of validation data. Recovery studies, standardization techniques, and selectivity/specificity are discussed with regard to the intrinsic value of various techniques that are used in validation. Models used for analytical calibration curves are explained in terms of their validity and limitations, along with a presentation of the most common ways to validate the model. Analytical sensitivity and detection limits are presented and discussed with regard to the usefulness of the various definitions. Appropriate means of testing precision and accuracy, the most important factors in assessing method quality, are presented. Stability and ruggedness testing are discussed along with a presentation of ways to assess data acceptability on a daily run basis.
This article was published in Pharm Res and referenced in Pharmaceutica Analytica Acta

Relevant Expert PPTs

Relevant Speaker PPTs

Recommended Conferences

Peer Reviewed Journals
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version